The OptiMA protocol in children with wasting and stunting – Authors' reply
Authors: Renaud Becquet, Cécile Cazes, Kevin Phelan, Béatrice Kalenga Tshiala, Susan Shepherd
Journal: The Lancet Global Health (2022)

Authors' reply We fully agree with Gabriele Rossi that the evaluation of simplified protocols aimed at optimising the management of uncomplicated acute malnutrition in children should include analyses dedicated to the most clinically vulnerable children. This is exactly the reason why the OptiMA-DRC trial was done in two stages. Beyond the evaluation already reported1Cazes C Phelan K Hubert V et al.Simplifying and optimising the management of uncomplicated acute malnutrition in children aged 6–59 months in the Democratic Republic of the Congo (OptiMA-DRC): a non-inferiority, randomised controlled trial.Lancet Glob Health. 2022; 10: e510-e520Summary Full Text Full Text PDF PubMed Scopus (3) Google Scholar in the entire population of children presenting with acute malnutrition, defined as a mid-upper-arm circumference (MUAC) of less than 125 mm, a weight-for-height Z score (WHZ) of less than –3, or oedema, we then continued to enrol children with a MUAC of less than 115 mm, a WHZ of less than –3, or an oedema at baseline, so that we had enough statistical power to compare across study groups the proportion of children who met the WHO definition of severe acute malnutrition2WHO and UNICEFWHO child growth standards and the identification of severe acute malnutrition in infants and children: a joint statement by the World Health Organization and the United Nations Children's Fund. World Health Organization, Geneva2009Google Scholar who recovered. This evaluation among children with severe acute malnutrition is reported elsewhere3Cazes C Phelan K Hubert V et al.Optimising the dosage of ready-to-use therapeutic food in children with uncomplicated severe acute malnutrition: a non-inferiority randomised controlled trial in the Democratic Republic of Congo.SSRN. 2022; (published online May 13.) (preprint).https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4099994Crossref Google Scholar and showed that the proportion of children in the trial who recovered during the 6-month follow-up was non-inferior in the OptiMA group (96% in OptiMA group vs 98% in the standard group; difference 2·0%, 95% CI–2·0 to 6·4). There was severe stunting (ie, height-for-age Z [HAZ] score <–3) among children presenting with acute malnutrition in 45% of children in the standard treatment group and in 40% of children in the OptiMA group at baseline and the difference between groups was not statistically significant (p=0·1620). We used logistic regression analysis to further investigate whether a HAZ of less than –3 at baseline was associated with the primary endpoint of a favourable outcome at 6 months and there was no association, even after adjustment for potential confounders. At 6 months after randomisation, the proportion of children with severe stunting was 71% in the standard treatment group and 65% in the OptiMA group (p=0·057). Our hypothesis to explain this almost statistically significant difference is that 71% of children in the standard treatment group received a nutritional treatment, whereas 100% of the children in the OptiMA group received such treatment. This difference contributed to further deterioration in the nutritional status of children in the standard treatment group. Our interpretation is that integrating severe and moderate acute malnutrition treatment into one programme, using one product, could lead to better nutritional status at 6 months after programme inclusion. We also agree that it is crucial to evaluate the OptiMA strategy among children presenting with a combination of wasting and stunting, who are at the greatest risk of short-term mortality.4Myatt M Khara T Schoenbuchner S et al.Children who are both wasted and stunted are also underweight and have a high risk of death: a descriptive epidemiology of multiple anthropometric deficits using data from 51 countries.Arch Public Health. 2018; 76: 28Crossref PubMed Scopus (67) Google Scholar A secondary analysis restricted to these most clinically vulnerable children is currently underway to investigate whether there was a difference in safety and recovery outcomes between study groups. KP serves on the Social Purposes Advisory Commission of Nutriset, a main producer of lipid-based nutrient supplement products. All other authors declare no competing interests. Simplifying and optimising the management of uncomplicated acute malnutrition in children aged 6–59 months in the Democratic Republic of the Congo (OptiMA-DRC): a non-inferiority, randomised controlled trialIn this non-inferiority trial treating children with MUAC of less than 125 mm or oedema, decreasing RUTF dose according to MUAC and weight increase proved to be a superior strategy to the standard protocol in the Democratic Republic of the Congo. These results demonstrate the safety and benefits of an approach that could substantially increase access to treatment for millions of children with acute malnutrition in sub-Saharan Africa. Full-Text PDF Open AccessThe OptiMA protocol in children with wasting and stuntingIn their open-label, non-inferiority, randomised controlled trial, Cécile Cazes and colleagues (April, 2022)1 assessed the efficacy, safety, and cost implications of a single protocol for moderate acute and severe acute malnutrition management, using only ready-to-use therapeutic food (RUTF) at a decreasing dose as weight and mid-upper-arm circumference (MUAC) increase (OptiMA strategy) in the Democratic Republic of the Congo. Full-Text PDF Open Access